An interventional study of Electroacupuncture and Sham Acupuncture in Postoperative Pain, Stress, Psychological and Impacted Lower Third Molar, sponsored by University of Zagreb. Not yet recruiting at 1 site in Croatia. Open to participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by University of Zagreb · Not applicable, Interventional, and Treatment
This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.
Perioperative pain and stress during surgical extraction of impacted lower third molars remain clinically relevant despite the use of local anesthesia. Psychological factors such as dental anxiety and physiological stress responses contribute to variability in pain perception and perioperative outcomes. Electroacupuncture has been proposed as a non-pharmacological adjunct that may modulate both nociceptive and stress-related pathways through neurohumoral mechanisms, including endogenous opioid release and autonomic regulation.
This prospective randomized controlled trial is designed to evaluate the effect of electroacupuncture as an adjunct to local anesthesia on perioperative response in patients undergoing ambulatory surgical extraction of impacted lower third molars. The study incorporates a three-arm parallel design, including electroacupuncture, sham acupuncture, and standard care without acupuncture, allowing differentiation between specific and non-specific effects of the intervention.
An integrated assessment approach will be used to capture multiple dimensions of the perioperative response, including subjective, biological, and physiological components. This design enables a comprehensive evaluation of the interaction between stress, autonomic activation, and nociceptive processing in a standardized oral surgery model. The findings are expected to contribute to the understanding of the clinical value of electroacupuncture as an adjunctive modality in perioperative care.
Exclusion Criteria:
Participants receive electroacupuncture for 15 minutes prior to administration of local anesthesia, according to a standardized protocol involving selected local and distal acupuncture points. Electrical stimulation is applied using a digital electroacupuncture device at an individually adjusted intensity sufficient to produce a clear sensation without pain or discomfort. Following the intervention, participants undergo standard surgical extraction of the impacted lower third molar under local anesthesia.
Procedure: Electroacupuncture
Participants receive a sham acupuncture procedure for 15 minutes prior to administration of local anesthesia. This involves superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation, mimicking the procedural aspects of electroacupuncture without therapeutic effect. The duration and conditions are identical to the electroacupuncture group. After the procedure, participants undergo standard surgical extraction under local anesthesia.
Procedure: Sham Acupuncture
Participants receive standard care consisting of local anesthesia and surgical extraction of the impacted lower third molar without any acupuncture intervention. All other aspects of perioperative management are consistent with routine clinical practice.
Electroacupuncture is applied for 15 minutes prior to local anesthesia using a standardized protocol with selected acupuncture points. Electrical stimulation is delivered via a digital electroacupuncture device at an individually adjusted intensity to produce a clear but non-painful sensation.
Sham acupuncture consists of superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation. The procedure mimics the active intervention in duration and setting but is designed to have no therapeutic effect.
Perioperative Pain Intensity
Perioperative pain intensity assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores represent a worse outcome.
Time frame: Baseline and 30 minutes after surgical extraction
Perceived Stress
Perceived stress assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no stress and 10 indicates the highest perceived stress, and the 10-item Perceived Stress Scale (PSS-10); higher scores on both scales indicate greater perceived stress and a worse outcome.
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Cortisol Levels
Salivary cortisol concentrations measured as a biomarker of stress response using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Alpha-Amylase Levels
Salivary alpha-amylase concentrations measured as an indicator of sympathetic activity using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline and 30 minutes after surgical extraction
Salivary Substance P Levels
Salivary substance P concentrations measured using ELISA as a biomarker of nociceptive response.
Time frame: Baseline and 30 minutes after surgical extraction
Systolic Blood Pressure
Systolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg).
Time frame: Baseline and immediately after surgical extraction
Diastolic Blood Pressure
Diastolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg).
Time frame: Baseline and immediately after surgical extraction
Heart Rate
Heart rate measured using a validated automated digital monitor as an indicator of autonomic response, reported in beats per minute (bpm).
Time frame: Baseline and immediately after surgical extraction
Plan to share: No — Individual participant data will not be shared due to privacy considerations and the absence of a predefined data-sharing plan within this investigator-initiated study. Data will be reported in aggregate form in scientific publications.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Zagreb